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U.S. Department of Health and Human Services

About FDA

Number of pending pre-Animal Generic Drug User Fee Act (AGDUFA) submissions to review at the end of the month

Dictionary: A generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration. In order for a generic animal drug to be marketed in the United States, it must be the subject of an approved ANADA. Prompt evaluation of applications for generic new animal drugs enhances the cost-effectiveness and predictability of new animal drug development. The effect of reducing the backlog of generic new animal drug submissions is anticipated to increase the number of generic new animal drug applications submitted.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009093
Nov 2009069
Dec 2009054
Jan 2010030
Feb 2010024
Mar 2010011
Apr 201003
May 201003
Jun 201003
Jul 201003
Aug 201000
Sep 201000

FY 2010 Year End: 0

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.